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세계의 의료기기 감시 시장 보고서(2025년)
Medical Devices Vigilance Global Market Report 2025
상품코드 : 1825449
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

의료기기 감시 시장의 규모는 향후 수년간 강력한 성장이 예상됩니다. 2029년에는 연평균 성장률(CAGR) 8.8%로 1,368억 6,000만 달러로 성장할 전망입니다. 예측기간의 성장은 의료기기의 리콜 시스템 출시 증가, 의료기기 시판 후 조사 프로그램 증가, 보고되는 부작용 증가, 치료제 및 수술 수요 증가, 환자 안전규제와 관련된 복잡성 증가 등에 기인할 것으로 예상됩니다. 예측기간의 주요 동향으로는 기술의 진보, 국제의료기기규제포럼(IMDRF)의 틀, 국경을 넘은 안전정보 교환 강화, 원격환자 모니터링 기기, 3D프린팅, 개별화기기 등이 있습니다.

향후 5년간의 예측 성장률 8.8%는 과거 예측에서 0.2% 소폭 감소한 수치입니다. 이러한 성장세 둔화는 주로 미국과 다른 국가 간의 관세의 영향 때문입니다. 무역 마찰은 EU 및 싱가포르에서 개발된 부작용 보고 플랫폼 및 사이버 보안 컴플라이언스 툴의 가격을 상승시켜 시판 후 조사 지연 및 규제 준수 비용 상승을 초래하여 미국 환자 안전 모니터링을 저해할 수 있습니다. 또한 상호관세와 무역의 긴장과 한계 증가로 인한 세계 경제와 무역에 대한 악영향으로 인해 그 영향이 더욱 광범위해질 것으로 예상됩니다.

의료 리콜 건수 증가는 향후 의료기기 감시 시장의 성장을 가속할 것으로 예측됩니다. 의료 리콜은 규제 당국, 제조업체 또는 판매자가 공중 보건에 위험을 초래하거나 규제 기준을 준수하지 않는 의료 제품을 철거하거나 수정하기 위해 취하는 조치를 의미합니다. 의료기기 모니터링은 부작용, 결함, 안전 우려를 파악하기 위해 시장에 유통되는 의료기기를 지속적으로 모니터링하는 것을 의미하며, 특정한 경우에는 규제 당국에 보고되며, 추가 조사 및 정당한 이유가 있으면 제품 회수로 이어질 수 있습니다. 예를 들어, 2022년 12월 미국 연방 정부기관인 식품의약국(FDA)은 의료기기의 리콜 증가를 관측했으며, 2022년에는 442건의 리콜이 기록되어 2021년 331건에서 약 10% 증가했습니다. 따라서 의료 리콜 건수 증가는 의료기기 감시 시장의 성장을 가속하고 있습니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역전쟁과 관세, 그리고 코로나 및 회복이 시장에 미치는 영향을 포함한 거시경제 시나리오

제5장 세계의 성장 분석과 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별/국가별 분석

제8장 아시아태평양 시장

제9장 중국 시장

제10장 인도 시장

제11장 일본 시장

제12장 호주 시장

제13장 인도네시아 시장

제14장 한국 시장

제15장 서유럽 시장

제16장 영국 시장

제17장 독일 시장

제18장 프랑스 시장

제19장 이탈리아 시장

제20장 스페인 시장

제21장 동유럽 시장

제22장 러시아 시장

제23장 북미 시장

제24장 미국 시장

제25장 캐나다 시장

제26장 남미 시장

제27장 브라질 시장

제28장 중동 시장

제29장 아프리카 시장

제30장 경쟁 구도와 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장 경쟁 벤치마킹과 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장의 잠재력이 높은 국가, 부문, 전략

제36장 부록

CSM
영문 목차

영문목차

Medical device vigilance refers to monitoring and reporting adverse events or incidents related to the use of medical devices. It is a critical component of post-market surveillance to ensure the safety and effectiveness of medical devices throughout their lifecycle. It identifies and addresses potential risks associated with medical devices, ensures patient safety, and maintains public trust in the healthcare system.

The main delivery modes of medical devices vigilance are on-demand and on-premise. On-demand medical device vigilance delivery mode refers to a system or approach where medical device vigilance services, such as monitoring, reporting, risk assessment, and communication related to adverse events or incidents with medical devices, are provided as needed or requested by healthcare providers, manufacturers, or regulatory authorities. It is used for therapeutics, diagnostics, surgical, research, and other applications by end-users such as original equipment manufacturers (OEMs), clinical research organizations (CROs), and business process outsourcing (BPO) firms.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sharp rise in U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the healthcare sector, especially in the supply of essential medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are grappling with higher costs for imported surgical tools, imaging systems, and consumables like syringes and catheters, many of which have limited domestic substitutes. These escalating expenses are putting pressure on healthcare budgets, prompting some providers to delay equipment upgrades or pass increased costs on to patients. Furthermore, tariffs on raw materials and components are disrupting the manufacturing of vital drugs and devices, leading to supply chain delays. In response, the industry is adopting diversified sourcing strategies, expanding local production where feasible, and pushing for tariff exemptions on critical medical products.

The main delivery modes of medical devices vigilance are on-demand and on-premise. On-demand medical device vigilance delivery mode refers to a system or approach where medical device vigilance services, such as monitoring, reporting, risk assessment, and communication related to adverse events or incidents with medical devices, are provided as needed or requested by healthcare providers, manufacturers, or regulatory authorities. It is used for therapeutics, diagnostics, surgical, research, and other applications by end-users such as original equipment manufacturers (OEMs), clinical research organizations (CROs), and business process outsourcing (BPO) firms.

The medical devices vigilance market size has grown strongly in recent years. It will grow from $90.26 billion in 2024 to $97.66 billion in 2025 at a compound annual growth rate (CAGR) of 8.2%. The growth in the historic period can be attributed to growing awareness regarding medical device vigilance, growing awareness among the physicians and patients regarding the benefits of medical devices vigilance, rising pressure on medical devices manufacturers, increasing number of government initiative, and rising medical device usage.

The medical devices vigilance market size is expected to see strong growth in the next few years. It will grow to $136.86 billion in 2029 at a compound annual growth rate (CAGR) of 8.8%. The growth in the forecast period can be attributed to increasing launches of recall systems for medical devices, increasing number of post market surveillance programs for medical devices, increasing number of adverse events reported, increasing need for therapeutics and surgical procedures, and growing complexity related to patient safety regulations. Major trends in the forecast period include technological advancements, international medical device regulators forum (IMDRF) framework, enhances the exchange of safety information across borders, remote patient monitoring devices, 3D printing and personalized devices.

The forecast of 8.8% growth over the next five years reflects a slight reduction of 0.2% from the previous projection. This reduction is primarily due to the impact of tariffs between the US and other countries. Trade tensions could hinder U.S. patient safety monitoring by inflating prices of adverse event reporting platforms and cybersecurity compliance tools developed in the EU and Singapore, resulting in slower post-market surveillance and higher regulatory compliance costs. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.

The increasing number of medical recalls is expected to propel the growth of the medical device vigilance market going forward. Medical recalls refer to the action taken by regulatory authorities, manufacturers, or distributors to remove or correct medical products that pose a risk to public health or do not comply with regulatory standards. Medical device vigilance entails continuous monitoring of medical devices in the market to identify adverse events, malfunctions, or safety concerns that, upon identification, are reported to regulatory authorities, potentially leading to further investigation and, if warranted, a product recall. For instance, in December 2022, the Food and Drug Administration (FDA), a US-based federal agency, observed a rise in medical device recalls, with 442 recalls documented in 2022, up from 331 in 2021, an almost 10% increase from 2021. Therefore, the increasing number of medical recalls is driving the growth of the medical device vigilance market.

Major companies operating in the medical device devices vigilance market are developing innovative products, such as quality management software, to improve customer satisfaction. Quality management software (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. For instance, in December 2022, Greenlight Guru, a US-based company providing systems and software to medical device companies, launched QMS software designed to help medical device companies modernize their processes, cut time from clinical testing, and bring safer products to market faster. Greenlight Guru's software is pre-validated per FDA and ISO best practices, aiming to help companies comply with the ever-changing standards. The company also offers training and certifications to help advance careers in product development, quality, and regulatory assurance.

In January 2024, GE Healthcare, a US-based medical technology company that offers a diverse portfolio of products, solutions, and services, acquired MIM Software Inc. for an undisclosed amount. The acquisition aims to reinforce GE HealthCare's digital strategy and enhance its imaging portfolio, particularly in medical device vigilance. MIM Software Inc. is a US-based company that provides services related to medical device surveillance through its specialization in medical imaging analysis and artificial intelligence (AI) solutions.

Major companies operating in the medical devices vigilance market are Johnson & Johnson, Intel Corporation, Oracle Corporation, Medtronic, Siemens Healthineers, RELX Group plc, MasterControl Inc., Laerdal Medical, Numerix, Smithers, Omnify Software Inc., Freyr, Sparta Systems, MDI Consultants Inc., Greenlight Guru, Jama Software, Sarjen Systems Pvt. Ltd, Arena Solutions Inc., Xybion Corporation, ZEINCRO Group, Extedo Gmbh, AssurX Inc., AB-Cube, Panacea Pharma Projects Limited, Qvigilance, General Electric (GE) Healthcare, Philips Healthcare, Baxter International, Stryker Corporation, Boston Scientific

North America was the largest region in the medical devices vigilance market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the medical devices vigilance market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the medical devices vigilance market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The medical device vigilance market consists of revenues earned by entities by providing services such as adverse event reporting, post-market surveillance, risk management, quality management systems, and regulatory compliance. The market value includes the value of related goods sold by the service provider or included within the service offering. The medical device vigilance market also includes sales of data collection devices, communication devices, data storage and processing devices, medical imaging equipment, and wearable devices. Values in this market are 'factory gate' values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Medical Devices Vigilance Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on medical devices vigilance market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for medical devices vigilance ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The medical devices vigilance market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

Scope

Table of Contents

1. Executive Summary

2. Medical Devices Vigilance Market Characteristics

3. Medical Devices Vigilance Market Trends And Strategies

4. Medical Devices Vigilance Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global Medical Devices Vigilance Growth Analysis And Strategic Analysis Framework

6. Medical Devices Vigilance Market Segmentation

7. Medical Devices Vigilance Market Regional And Country Analysis

8. Asia-Pacific Medical Devices Vigilance Market

9. China Medical Devices Vigilance Market

10. India Medical Devices Vigilance Market

11. Japan Medical Devices Vigilance Market

12. Australia Medical Devices Vigilance Market

13. Indonesia Medical Devices Vigilance Market

14. South Korea Medical Devices Vigilance Market

15. Western Europe Medical Devices Vigilance Market

16. UK Medical Devices Vigilance Market

17. Germany Medical Devices Vigilance Market

18. France Medical Devices Vigilance Market

19. Italy Medical Devices Vigilance Market

20. Spain Medical Devices Vigilance Market

21. Eastern Europe Medical Devices Vigilance Market

22. Russia Medical Devices Vigilance Market

23. North America Medical Devices Vigilance Market

24. USA Medical Devices Vigilance Market

25. Canada Medical Devices Vigilance Market

26. South America Medical Devices Vigilance Market

27. Brazil Medical Devices Vigilance Market

28. Middle East Medical Devices Vigilance Market

29. Africa Medical Devices Vigilance Market

30. Medical Devices Vigilance Market Competitive Landscape And Company Profiles

31. Medical Devices Vigilance Market Other Major And Innovative Companies

32. Global Medical Devices Vigilance Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Medical Devices Vigilance Market

34. Recent Developments In The Medical Devices Vigilance Market

35. Medical Devices Vigilance Market High Potential Countries, Segments and Strategies

36. Appendix

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